Prescription drug · NDA
Alvaiz (Eltrombopag) NDC 0480-3273
Eltrombopag choline 9 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3273-56 | 00480327356 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56)Marketed from Feb 13, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Alvaiz
- Generic name (nonproprietary)
- eltrombopag
- Active ingredients
- Eltrombopag choline — 9 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216774
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Increased Megakaryocyte Maturation (Physiologic effect)Increased Platelet Production (Physiologic effect)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Thrombopoietin Receptor Agonists (Mechanism)UGT1A1 Inhibitors (Mechanism)UGT1A3 Inhibitors (Mechanism)UGT1A4 Inhibitors (Mechanism)UGT1A6 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)UGT2B15 Inhibitors (Mechanism)UGT2B7 Inhibitors (Mechanism)
- Identifiers
- Product ID 0480-3273_6a49af27-c1fc-4b62-8c30-fb27bc4c5a3eSPL ID 6a49af27-c1fc-4b62-8c30-fb27bc4c5a3eSPL set ID ed51e463-7a03-4858-bbd2-882ce4753d5aRxCUI 2675187, 2675193, 2675195, 2675197, 2675199, 2675201, 2675203, 2675205UNII F9G8XE24IBUPC 0304803274560, 0304803273563
- Pharmacologic class
- Thrombopoietin Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400480327356followed by a unit qualifier and the quantityPackage 00480-3273-56. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ALVAIZ is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initi…
Excerpt only. Read the full label for complete information.
About NDC 0480-3273
- What is NDC 0480-3273?
- 0480-3273 is the product NDC for Alvaiz (eltrombopag), Eltrombopag choline 9 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alvaiz (Eltrombopag).
- What is the active ingredient?
- Eltrombopag choline.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alvaiz?
- 3 other product NDCs are listed under this name. See all Alvaiz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alvaiz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alvaizeltrombopag | Eltrombopag choline 18 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3274 | 00480-3274-56 |
| Alvaizeltrombopag | Eltrombopag choline 36 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3275 | 00480-3275-56 |
| Alvaizeltrombopag | Eltrombopag choline 54 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3276 | 00480-3276-56 |
Other NDCs under NDA 216774
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Alvaizeltrombopag | Eltrombopag choline 18 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3274 |
| Alvaizeltrombopag | Eltrombopag choline 36 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3275 |
| Alvaizeltrombopag | Eltrombopag choline 54 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3276 |